Piloting electronic informed consenting: A Pneumococcal Human Infection Study in Blantyre Malawi.

Electronic consent can potentially improve accuracy, workflow, and overall patient experience in clinical research. We explored the feasibility of using electronic consent in an ongoing human infection study in Blantyre. We dual-consented participants by both electronic and paper methods to assess the feasibility of electronic consent, and then compared benefits and challenges of the two methods. The approved paper consent forms were digitized using Open Data Kit (ODK). Healthy literate adult participants with no audio-visual impairments then self-administered the e-consenting materials while accompanied by a member of staff to answer questions, and then provided an e-signature. Signed e-consent forms were exported to secure servers for archiving. A copy of the signed form was printed and given to the volunteers. We piloted 110 participants to e-consenting, it was found to be user friendly, reduced documentation errors and enhanced data safety. The challenges included difficult digitization of ethics stamped documents, volunteer unfamiliarity with tablet user interface and its requirement of a working internet and printerE-consenting was feasible but required additional resource investment. Benefits included error minimization and data security.

电子知情同意（Electronic Consent）有望提升临床研究中的数据准确性、工作流程效率与患者整体体验。本研究针对布兰太尔（Blantyre）一项正在进行的人体感染研究，探索了电子知情同意的应用可行性。我们采用电子与纸质双渠道为受试者签署知情同意，以此评估电子知情同意的可行性，并对比两种方式的优势与挑战。经审核通过的纸质知情同意书通过开放数据套件（Open Data Kit, ODK）完成数字化处理。随后，无视听障碍且具备读写能力的健康成年受试者在工作人员陪同下（以便解答疑问）自行完成电子知情同意材料的填写，并签署电子签名。签署完成的电子知情同意书将导出至安全服务器进行存档，同时将签署完成的知情同意书副本打印后交付给受试者。我们共为110名受试者开展了电子知情同意试点，结果表明该流程操作友好，可减少文书错误并强化数据安全。本次试点遇到的挑战包括：加盖伦理审查章的文件数字化难度较高、受试者对平板用户界面不熟悉，以及该流程对可用网络与打印机的依赖。电子知情同意具备可行性，但需投入额外资源，其优势包括最大限度减少错误与保障数据安全。